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Active Biomarkers has decades of experience in bioanalytical services We have a proven track record supporting the development of key players'
preventive and therapeutic vaccines in both preclinical and clinical phases. Check what we can do for you!
Understanding how an investigational product modulates the immune system is of outstanding value in many therapeutic areas and indications. The enzyme-linked
immunosorbent spot (ELISpot) assay was firstly developed more than 30 years ago for the detection of antibody-secreting cells1,2. Since then, this method has become one of the most popular for documenting functionality of antigen-specific T cell responses in the context of therapies expected to modulate the immune system, such as preventive or therapeutic, universal or individualized vaccines, but also therapeutic antibodies, immune check-point inhibitors or oncolytic viral therapies, in many fields, including immuno-oncology, infectious diseases, autoimmunity, (neuro)inflammation or allergy.
If there are indisputable advantages (sensitivity, measure of cell function, low-cost assay) of the ELISpot assay for evaluating cell-mediated immunogenicity in large-scale
clinical trials, many factors, if not under control, may affect assay performance and outcomes.
Neuroinflammatory and neurodegenerative disorders, whatever their origin, lead to the accumulation of specific neuronal proteins in cerebrospinal fluid and blood. Neurofilament-Light chain (Nf-L) is one of the 3 subunits, with intermediate (Nf-M) and heavy (Nf-H) chains, constituting the main components of intermediate filaments in neurons. Neurofilaments are involved in axonal growth and maintenance, as well as electric transmission in the nervous sys. While displaying low turnover in non pathological conditions, neurofilaments rise up in cerebrospinal fluid and blood during neuroaxonal injury. The presence of Nf-L in blood has been shown to be a biomarker of differential diagnosis in some neurodegenerative disorders such as Amyotrophic Lateral Sclerosis, Parkinsonian disorders, but also of prognostic value for progression and response to therapy in Multiple Sclerosis (MS). Moreover, it is linked to disease activity in MS, Alzheimer’s, and Huntington’s. In these neurological pathologies, there is a need for targeting early stages of disease and monitoring therapeutic intervention in easily accessible biological fluids. It is then crucial that assays for monitoring this biomarker are robust, accurate, and reproducible, in other terms reliable.
Our team has qualified NF-Light Advantage Kit from Quanterix (ref: 102258) on the SIMOA HD-1 system, evaluating its performance in terms of dynamic range, precision, parallelism and selectivity, lot-to-lot consistency and stability for quantifying Nf-L in both plasma and serum matrices.
